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The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC)

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Simcere Zaiming

The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC)

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  • The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC)
  • The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3% & OS of 2.322yrs. vs 1.900yrs. & a P-III confirmatory trial
  • Enlituo (CMAB009), a recombinant EGFR mAb developed in partnership with Mabpharm, is categorized as a 2.4 class modified biologic & is produced by utilizing a protein production technology that prevents glycosylation modification which results in hypersensitivity

Ref: Simcere Zaiming | Image: Simcere Zaiming

Related Post:- Simcere Zaiming Entered into a Clinical Collaboration Agreement with MSD to Evaluate SIM0235 + Keytruda for Advanced Solid Tumors and Cutaneous T-cell Lymphoma

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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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